title: Cement directed kyphoplasty reduces cement leakage as compared with vertebroplasty: results of a controlled, randomized trial.
abstract: METHODS
  A novel randomized, controlled, unblinded clinical trial comparing 2 procedural interventions for painful osteoporotic vertebral compression fractures.
  
  
  OBJECTIVE
  The primary study objective was to evaluate cement leakage for a cement directed kyphoplasty system (CDKS) with anteriorly biased cement flow and vertebroplasty. The secondary study objective was to compare adjacent level fracture rates and vertebral body height for these 2 intervention methods.
  
  
  BACKGROUND
  Cement leakage remains a significant clinical problem associated with vertebroplasty and kyphoplasty procedures. Uncontrolled cement flow in the posterior direction can result in leakage into the vertebral veins or spinal canal, leading to potentially serious clinical complications.
  
  
  METHODS
  Seventy-seven patients with painful osteoporotic vertebral compression fractures were enrolled. Patients were randomized 2:1 for treatment with CDKS (49 patients, 65 levels) or vertebroplasty (28 patients, 39 levels). Cement leakage was evaluated from radiographs and computed tomographic scans. Three- and 12-month follow-ups included additional radiographs and computed tomographic scans to assess changes in vertebral body height and the incidence of new fractures.
  
  
  RESULTS
  Treatment with CDKS significantly reduced the number of levels with leaks and the total number of leaks per level, as compared with vertebroplasty (P = 0.0132 and P = 0.0012, respectively). Significantly, fewer lateral cortical and spinal canal leaks (posterior leaks) occurred in the CDKS group (P = 0.0050, P = 0.02260, respectively). Three adjacent level fractures occurred in the vertebroplasty group, as compared with 2 in the CDKS group. Vertebral body height maintenance was equivalent.
  
  
  CONCLUSIONS
  Cement directed kyphoplasty effectively reduces posterior cement leakage, reducing the risk of leakage related complications.
  
  
  METHODS
  2.
authors.affiliation: *Universitaetsklinikum Frankfurt, Frankfurt am Main, Germany †Universitatsmedizin CHARITÉ, Klinik fur Unfall und Wiederherstellungschirurgie, Berlin, Germany ‡Klinikum Ernst-von Bergmann GmbH, Potsdam, Germany §Paracelsus Klinik, Marl, Germany; and ¶University of Massachusetts Medical School, Department of Radiology and Neurological Surgery, Worcester, Massachusetts.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Vogl
authors.forename: Robert
authors.initials: R
authors.lastname: Pflugmacher
authors.forename: Johannes
authors.initials: J
authors.lastname: Hierholzer
authors.forename: Gerd
authors.initials: G
authors.lastname: Stender
authors.forename: Matthew
authors.initials: M
authors.lastname: Gounis
authors.forename: Ajay
authors.initials: A
authors.lastname: Wakhloo
authors.forename: Christian
authors.initials: C
authors.lastname: Fiebig
authors.forename: Renate
authors.initials: R
authors.lastname: Hammerstingl
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001843:Bone Cements / Q000009:adverse effects / Q000627:therapeutic use*; D005119:Extravasation of Diagnostic and Therapeutic Materials / Q000000981:diagnostic imaging / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D050815:Fractures, Compression / Q000601:surgery*; D006801:Humans; D058498:Kyphoplasty / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D058866:Osteoporotic Fractures / Q000601:surgery*; D011183:Postoperative Complications / Q000000981:diagnostic imaging / Q000209:etiology; D011446:Prospective Studies; D016103:Spinal Fractures / Q000601:surgery*; D013131:Spine / Q000000981:diagnostic imaging / Q000601:surgery; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D054854:Vertebroplasty / Q000009:adverse effects / Q000379:methods*
chemical_list: D001843:Bone Cements